TY - CHAP
T1 - Aligning XAI with EU Regulations for Smart Biomedical Devices
T2 - A Methodology for Compliance Analysis
AU - Sovrano, Francesco
AU - Lognoul, Michael
AU - Vilone, Giulia
N1 - Publisher Copyright:
© 2024 The Authors.
PY - 2024/10/16
Y1 - 2024/10/16
N2 - Significant investment and development have gone into integrating Artificial Intelligence (AI) in medical and healthcare applications, leading to advanced control systems in medical technology. However, the opacity of AI systems raises concerns about essential characteristics needed in such sensitive applications, like transparency and trustworthiness. Our study addresses these concerns by investigating a process for selecting the most adequate Explainable AI (XAI) methods to comply with the explanation requirements of key EU regulations in the context of smart bioelectronics for medical devices. The adopted methodology starts with categorising smart devices by their control mechanisms (open-loop, closed-loop, and semi-closed-loop systems) and delving into their technology. Then, we analyse these regulations to define their explainability requirements for the various devices and related goals. Simultaneously, we classify XAI methods by their explanatory objectives. This allows for matching legal explainability requirements with XAI explanatory goals and determining the suitable XAI algorithms for achieving them. Our findings provide a nuanced understanding of which XAI algorithms align better with EU regulations for different types of medical devices. We demonstrate this through practical case studies on different neural implants, from chronic disease management to advanced prosthetics. This study fills a crucial gap in aligning XAI applications in bioelectronics with stringent provisions of EU regulations. It provides a practical framework for developers and researchers, ensuring their AI innovations advance healthcare technology and adhere to legal and ethical standards.
AB - Significant investment and development have gone into integrating Artificial Intelligence (AI) in medical and healthcare applications, leading to advanced control systems in medical technology. However, the opacity of AI systems raises concerns about essential characteristics needed in such sensitive applications, like transparency and trustworthiness. Our study addresses these concerns by investigating a process for selecting the most adequate Explainable AI (XAI) methods to comply with the explanation requirements of key EU regulations in the context of smart bioelectronics for medical devices. The adopted methodology starts with categorising smart devices by their control mechanisms (open-loop, closed-loop, and semi-closed-loop systems) and delving into their technology. Then, we analyse these regulations to define their explainability requirements for the various devices and related goals. Simultaneously, we classify XAI methods by their explanatory objectives. This allows for matching legal explainability requirements with XAI explanatory goals and determining the suitable XAI algorithms for achieving them. Our findings provide a nuanced understanding of which XAI algorithms align better with EU regulations for different types of medical devices. We demonstrate this through practical case studies on different neural implants, from chronic disease management to advanced prosthetics. This study fills a crucial gap in aligning XAI applications in bioelectronics with stringent provisions of EU regulations. It provides a practical framework for developers and researchers, ensuring their AI innovations advance healthcare technology and adhere to legal and ethical standards.
UR - http://www.scopus.com/inward/record.url?scp=85213383584&partnerID=8YFLogxK
U2 - 10.3233/faia240568
DO - 10.3233/faia240568
M3 - Chapter
T3 - Frontiers in Artificial Intelligence and Applications
SP - 826
EP - 833
BT - Proceedings of the 27th European Conference on Artificial Intelligence
A2 - Endriss, Ulle
A2 - Melo, Francisco S.
A2 - Bach, Kerstin
A2 - Bugarin-Diz, Alberto
A2 - Alonso-Moral, Jose M.
A2 - Barro, Senen
A2 - Heintz, Fredrik
PB - IOS Press
CY - Amsterdam
ER -